• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012275-12
Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Difficult to Advance (2920)
Patient Problems Embolism (1829); Myocardial Infarction (1969); Pulmonary Edema (2020)
Event Date 10/27/2020
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history did not indicate a lot specific quality issue. The reported patient effects of myocardial infarction and embolism are listed in the trek rx and mini trek rx coronary dilatation catheter instructions for use as known patient effects of coronary procedures. As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the anatomy and/or other devices resulted in the reported difficult to advance and the reported difficult to remove. During removal manipulation of the device/interaction with the previously deployed 3. 0x33mm xience sierra stent resulted in the reported balloon material separation/ material rupture. The reported difficulties possibly contributed to the reported patient effects; however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. The treatments appear to be related to the operational context of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the procedure was to treat an occluded lesion located in the proximal left anterior descending (plad), left main (lm) and left circumflex coronary (lcx) arteries. A 3. 0x33mm xience sierra stent was implanted in the lcx. Kissing balloon was then to be performed. A 3. 25x12mm trek balloon was advanced with slight resistance into the lcx. When the 3. 5x12mm trek balloon was placed in the lm/plad, there was slight movement of the balloon in the lcx. An attempt was made to remove the balloon from the lcx, but it was stuck. Trouble shooting was performed and the balloon was removed with resistance, and once removed, it was noted that the balloon was torn and the lcx was occluded. Optical coherence tomography (oct) was performed and a piece of balloon was noted attached to the 3. 0x33mm xience sierra stent in the lcx. The piece of the balloon was not able to be removed and remains in the patient. The patient experienced an acute myocardial infarction and acute lung edema and was transferred to the intensive care unit and placed extracorporeal membrane oxygenation (ecmo). No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key10932260
MDR Text Key219140829
Report Number2024168-2020-10087
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2022
Device Model Number1012275-12
Device Catalogue Number1012275-12
Device Lot Number90207G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/02/2020 Patient Sequence Number: 1
Treatment
3.00X33MM XIENCE SIERRA DES; 3.5X12MM TREK BALLOON
-
-